Back to results

Comparation of Chidamide Plus VRD (Bortezomib, Lenalidomide, Dexamethasone) With VRD Regimen for Primary High-Risk Multiple Myeloma Patients

Primary Purpose

Multiple Myeloma

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Chidamide+VRD

VRD

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1.Diagnosed as multiple myeloma, and has one of the above:
1. high risk karyotype, such as 17p-，t（4；14），t（14；16），t（14；20）或1q gain,1p-, double hit myeloma, triple hit myeloma, etc;
2. RISS-3;
3. IgD/IgE MM;
4. with measurable extra-medullary plasmacytoma;
5. flowcytometry showed peripheral blood plasma cell ≥0.165%；
2.Secretory MM should have measurable markers, including:
1. specific M protein value (≥5g/L)；
2. and/or involved flc ≥100mg/L；
3. and/or measurable extramedullary foci (diameter>1cm on CT);
3.Age≥18 years, male or female;
4.ECOG 0-2 points, with life expectance ≥3 months; GA score <2;
5.ALT/AST level <2.5 times of the maximum of normal range; total bilirubin<1.5 times of normal maximum；
6.Neutrophil count≥1.5×109/L, platelet count≥50×109/L;
7.eGFR≥40ml/min，except in the case of myeloma-related nephropathy;
8.Normal left ventricular ejaculation rate, NYHA stage 1, pulmonary function GOLD stage 1;
9.Willing to accept the possibility of potential adverse events and efficacy observation by the investigators;
10.Being able to understand and signing the written consent, which should be signed prior to any procedure of the trial.

Exclusion Criteria:

1.With ≥2 degree of peripheral neuropath or with pain;
2.Having received any of the medicine of the experiment regimen within 30 days prior to enrollment, pain-relieving radiotherapy is allowed;
3.With severe pulmonary/cardiac disfunction (including history of QT interval elongation, ventricular tachycardia, ventricular fibrillation, myocardial infraction) or other severe organ malfunction;
4.Patients in pregnancy or lactation;
5.Allergic constitution or being allergic to any drug within the regimen of the trial;
6.With uncontrolled mental diseases;
7.With active infection;
8.With non-myeloma-associated acute renal dysfunction;
9.With active hepatitis;
10.HIV positive;
11.History of other malignant tumor within 5 years prior to enrollment; except for the case of in situ cervical cancer and non-malignant melanoma;
12.With other conditions that the investigators think unfit for the trial.

Sites / Locations

First Affiliated Hospital, Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chidamide plus VRD

VRD

Arm Description

Chidamide:30mg d0,d3,d7,d10/Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14

Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14

Outcomes

Primary Outcome Measures

complete remission rate

complete remission rate after treated by the corresponding regimen

incidence and severity of adverse events

any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure

Secondary Outcome Measures

progression free survival

from date of inclusion to date of progression, relapse, or death from any cause

overall survival

from the date of inclusion to date of death, irrespective of cause

Full Information

NCT ID

NCT04025450

First Posted

July 17, 2019

Last Updated

July 17, 2019

Sponsor

The First Affiliated Hospital of Soochow University

1. Study Identification

Unique Protocol Identification Number

NCT04025450

Brief Title

Comparation of Chidamide Plus VRD (Bortezomib, Lenalidomide, Dexamethasone) With VRD Regimen for Primary High-Risk Multiple Myeloma Patients

Official Title

Comparation of Chidamide Plus VRD (Bortezomib, Lenalidomide, Dexamethasone) With VRD Regimen for Primary High-Risk Multiple Myeloma Patients, a Phase I/II, Multiple Center, Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Recruiting

Study Start Date

July 15, 2019 (Anticipated)

Primary Completion Date

July 15, 2029 (Anticipated)

Study Completion Date

July 15, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First Affiliated Hospital of Soochow University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

In the phase I trial, dose escalation of chidamide will be performed at 4 different dosages (15mg, 20mg, 25mg, 30mg) for optimal dosage, in the phase II trial, the safety and efficacy of chidamide+VRD will be compared with that of VRD regimen.

Detailed Description

In the phase I trial, dose escalation of chidamide will be performed at 4 different dosages (15mg, 20mg, 25mg, 30mg) for optimal dosage, which will be determined by efficacy and safety profiles of the patients; afterward, the optimal dosage of chidamide will be combined with VRD regimen, patients will be randomly assigned to chidamide+VRD group or VRD group, and their efficacy and safety will be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

In this trial, patients will be randomly assigned to chidamide+VRD group or VRD group, and then treated with the corresponding regimen, and their safety and efficacy will be evaluated.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chidamide plus VRD

Arm Type

Experimental

Arm Description

Chidamide:30mg d0,d3,d7,d10/Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14

Arm Title

VRD

Arm Type

Active Comparator

Arm Description

Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14

Intervention Type

Drug

Intervention Name(s)

Chidamide+VRD

Intervention Description

Chidamide:30mg d0,d3,d7,d10/Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14

Intervention Type

Drug

Intervention Name(s)

VRD

Intervention Description

Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14

Primary Outcome Measure Information:

Title

complete remission rate

Description

complete remission rate after treated by the corresponding regimen

Time Frame

at the time point 1 month after the last cycle

Title

incidence and severity of adverse events

Description

Time Frame

from the date of the start of treatment to 36 months after last patient's enrollment

Secondary Outcome Measure Information:

Title

progression free survival

Description

from date of inclusion to date of progression, relapse, or death from any cause

Time Frame

from the day of treatment to the date of first documented progression，up to 36 months after the last patient's enrollment;

Title

overall survival

Description

from the date of inclusion to date of death, irrespective of cause

Time Frame

from the day of treatment to the date of first documented progression，up to 36 months after the last patient's enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1.Diagnosed as multiple myeloma, and has one of the above: high risk karyotype, such as 17p-，t（4；14），t（14；16），t（14；20）或1q gain,1p-, double hit myeloma, triple hit myeloma, etc; RISS-3; IgD/IgE MM; with measurable extra-medullary plasmacytoma; flowcytometry showed peripheral blood plasma cell ≥0.165%； 2.Secretory MM should have measurable markers, including: specific M protein value (≥5g/L)； and/or involved flc ≥100mg/L； and/or measurable extramedullary foci (diameter>1cm on CT); 3.Age≥18 years, male or female; 4.ECOG 0-2 points, with life expectance ≥3 months; GA score <2; 5.ALT/AST level <2.5 times of the maximum of normal range; total bilirubin<1.5 times of normal maximum； 6.Neutrophil count≥1.5×109/L, platelet count≥50×109/L; 7.eGFR≥40ml/min，except in the case of myeloma-related nephropathy; 8.Normal left ventricular ejaculation rate, NYHA stage 1, pulmonary function GOLD stage 1; 9.Willing to accept the possibility of potential adverse events and efficacy observation by the investigators; 10.Being able to understand and signing the written consent, which should be signed prior to any procedure of the trial. Exclusion Criteria: 1.With ≥2 degree of peripheral neuropath or with pain; 2.Having received any of the medicine of the experiment regimen within 30 days prior to enrollment, pain-relieving radiotherapy is allowed; 3.With severe pulmonary/cardiac disfunction (including history of QT interval elongation, ventricular tachycardia, ventricular fibrillation, myocardial infraction) or other severe organ malfunction; 4.Patients in pregnancy or lactation; 5.Allergic constitution or being allergic to any drug within the regimen of the trial; 6.With uncontrolled mental diseases; 7.With active infection; 8.With non-myeloma-associated acute renal dysfunction; 9.With active hepatitis; 10.HIV positive; 11.History of other malignant tumor within 5 years prior to enrollment; except for the case of in situ cervical cancer and non-malignant melanoma; 12.With other conditions that the investigators think unfit for the trial.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chengcheng Fu, PhD

Phone

13962191404

fuzhengzheng@suda.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

chengcheng Fu, PhD

Organizational Affiliation

First Affiliated Hospital of Suzhou University

Official's Role

Principal Investigator

Facility Information:

Facility Name

First Affiliated Hospital, Soochow University

City

Suzhou

State/Province

Jiangsu

ZIP/Postal Code

215000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fu chengcheng, Phd

Phone

13962191404

fuchengcheng@suda.edu.cn

12. IPD Sharing Statement

Learn more about this trial

Comparation of Chidamide Plus VRD (Bortezomib, Lenalidomide, Dexamethasone) With VRD Regimen for Primary High-Risk Multiple Myeloma Patients

We'll reach out to this number within 24 hrs